WARREN, N.J., October 15, 2026
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, an investigational treatment for Type I allergic reactions, including anaphylaxis. The FDA classified the resubmission as a Class 2 response and assigned a Prescription Drug User Fee Act (PDUFA) goal action date of March 16, 2027. The company submitted the application on September 16, 2026, following positive topline results from human factors and pharmacokinetic (PK) studies announced in August. These studies were conducted to address items raised in the FDA’s January 30, 2026, Complete Response Letter. Anaphylm remains investigational and is subject to FDA review.
FDA Review Sets March 2027 Regulatory Milestone
The FDA’s acceptance confirms that the Anaphylm NDA resubmission was considered complete for review under the assigned Class 2 classification. The March 16, 2027 PDUFA goal date establishes the agency’s target date for taking regulatory action on the application. Aquestive said the resubmission followed additional human factors and pharmacokinetic studies intended to address the concerns identified in the earlier Complete Response Letter. Human factors studies assess how intended users interact with a product and its instructions, while pharmacokinetic studies examine how a drug is absorbed and processed by the body. The company reported positive topline findings from these studies in August 2026. The latest regulatory milestone advances the review process, but acceptance of a resubmission does not mean the product has been approved. The FDA’s final decision will determine whether Anaphylm can be marketed in the United States.
Sublingual Film Designed for Epinephrine Rescue Treatment
Anaphylm is a polymer matrix-based epinephrine prodrug formulated as a sublingual film that begins dissolving upon contact and is designed for administration without water or swallowing. According to the company, the film is similar in size to a postage stamp and weighs less than an ounce, while its packaging is designed to be thinner and smaller than an average credit card. The compact format is intended to make the product portable in everyday settings, including a phone case or wallet. Aquestive is developing Anaphylm as a potential rescue treatment for severe allergic reactions, including anaphylaxis. If approved, the company says it would be the first and only oral rescue medication for these conditions. The FDA has conditionally approved the Anaphylm trade name for AQST-109, with final approval of the proprietary name dependent on approval of the product candidate itself.
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Commercial Preparation and Canadian Regulatory Plans
Alongside the U.S. review, Aquestive is continuing preparations for a potential commercial launch, contingent on regulatory approval. The company said it plans to work with the FDA to complete the review by the assigned goal date and is advancing its commercial readiness in parallel. Its Canadian New Drug Submission (NDS) for Anaphylm remains planned for the fourth quarter of 2026, extending the candidate’s regulatory strategy beyond the United States. Aquestive develops medicines using proprietary drug-delivery technologies, including oral-film formulations, and operates U.S. manufacturing facilities in Indiana, with headquarters in New Jersey. Its pipeline also includes AQST-108, an epinephrine topical gel being developed for potential dermatological indications. The company’s next key milestone for Anaphylm is the FDA’s regulatory action expected by March 16, 2027, while the Canadian submission represents a separate planned step in its international development strategy.
Source:::Aquestive Therapeutics,press release
